ATTUNE 2544-91-002Recalls & reported problems
Depuy (Ireland) · ATTUNE Knee System ALL POLY TIBIA IMPACTOR SIZE 3-5 · Class 1
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295443797), received between Jul 21, 2021 and Nov 19, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Break” (3 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break3
- Contamination /Decontamination Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 19, 2025Break; Break
THIS IS REPORT 3 OF 3 FOR (B)(4). IT WAS REPORTED THAT THREE ATTUNE IMPACTOR DEVICES BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23594497 ↗MalfunctionAug 11, 2021Break; Break
IT WAS REPORTED THAT THE ANTERIOR ALIGNMENT PEG BROKE WHILE IMPACTING. ALL PIECES WERE REMOVED FROM PATIENT. NO SURGICAL DELAY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12307181 ↗MalfunctionAug 11, 2021Break; Break
IT WAS REPORTED THAT THE ANTERIOR ALIGNMENT PEG BROKE WHILE IMPACTING. ALL PIECES WERE REMOVED FROM PATIENT. NO SURGICAL DELAY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12307171 ↗MalfunctionJul 29, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT ONE OF THE SURGEONS SAID THAT WE NEED TO DO SOMETHING ABOUT OUR ATTUNE ALL POLY IMPACTORS. HE STATED THAT THERE NEEDS TO BE A COLOR CHANGE AS THE WHITE COLOR OF THE IMPACTOR WAS TOO CLOSE IN COLOR TO THE BONE CEMENT AND THAT THE TINY CEMENT FLECKS ARE BEING MISSED IN STERILE PROCESSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12247844 ↗MalfunctionJul 21, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE CEMENT FRAGMENTS REMAIN ON WHILE IMPACTING AND CANNOT BE SEEN. IT WAS ALSO REPORTED A DIFFERENT COLOR IS NEEDED TO SEE RESIDUAL CEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12204822 ↗
Other IMPACTOR devices
- PINNACLE 2217-50-041Depuy (Ireland) · IMPACTOR4,295 reports
- ATTUNE 2544-01-006Depuy (Ireland) · IMPACTOR1 recall2,539 reports
- ATTUNE 2544-01-003Depuy (Ireland) · IMPACTOR1 recall1,498 reports
- ATTUNE 2544-01-017Depuy (Ireland) · IMPACTOR1 recall1,456 reports
- ATTUNE 2544-01-004Depuy (Ireland) · IMPACTOR1 recall875 reports
- DURALOC 2360-71-000Depuy Orthopaedics, Inc. · IMPACTOR716 reports
- SPECIALIST 2581-11-000Depuy (Ireland) · IMPACTOR704 reports
- INHANCE 6205-10-103Depuy (Ireland) · IMPACTOR337 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.